Preventing blood clots in cancer patients with central venous catheters

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the effectiveness and safety of rivaroxaban, a blood thinner, in preventing venous thromboembolism (VTE) in patients with active cancer who have central venous catheters (CVC) inserted within the last 72 hours. It is a double-blind, randomized controlled trial comparing a daily dose of 10mg rivaroxaban to a placebo. The study will be conducted across nine centers in Canada, focusing on a population at high risk for blood clots due to their cancer and CVC. Participants will be monitored for VTE occurrences and any adverse effects related to the medication.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients 18 years of age or older with a new or existing diagnosis of cancer and a CVC inserted in the last 72 hours.

Exclusion criteria:

1. CVC in place for \>72 hours
2. Patient requires anticoagulation for other indications
3. Concomitant use of dual antiplatelet therapy
4. Major bleeding event in the last 4 weeks
5. Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir).
6. Known pregnancy or plan to become pregnant in next 3 months
7. Severe renal insufficiency (Creatinine clearance \<30 mL/min (defined by Cockcroft-Gault) in the previous 3 months
8. Documented severe liver disease (e.g., acute clinical hepatitis, chronic active hepatitis or cirrhosis) in the previous 3 months
9. Known thrombocytopenia (platelet count \< 50x 109/L) in the previous 3 months
10. Known allergy to rivaroxaban
11. Life expectancy \<3 months
12. History of condition at increased bleeding risk including, but not limited to:

    1. cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the past 4 weeks.
    2. Chronic hemorrhagic disorder
13. Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin only
14. Refused or unable to obtain consent

Where it's running

• Nova Scotia Health
  Halifax, Nova Scotia, Canada Recruiting
• William Osler Health System
  Brampton, Ontario, Canada Recruiting
• HHS - Juravinski Hospital
  Hamilton, Ontario, Canada Recruiting
• Ottawa Hospital Research Institute- The Ottawa Hospital
  Ottawa, Ontario, Canada Recruiting
• Sault Area Hospital
  Sault Ste. Marie, Ontario, Canada Recruiting
• Niagara Health
  St. Catharines, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Dr. Marc Carrier — Ottawa Hospital Research Institute
• Study coordinator: Bashour Yazji
• Email: byazji@ohri.ca
• Phone: 613-737-8899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.